Regulation of genetically modified organisms in the European Union

Logo of the European Food Safety Authority.

The regulation of genetically modified organisms in the European Union is varied.^[1]

Overview of regulatory process

Scope

In its regulations the European Union considers genetically modified organisms only to be food and feed for all intents and practical purposes,^[2] in difference to the definition of genetically modified organisms which encompasses animals.

Approach

The EU uses the precautionary principle demanding a pre-market authorisation for any GMO to enter the market and a post-market environmental monitoring. Both the European Food Safety (EFSA) and the member states author a risk assessment. This assessment must show that the food or feed is safe for human and animal health and the environment "under its intended conditions of use".^[2]

As of 2010, the EU treats all genetically modified crops (GMO crops), along with irradiated food as "new food". They are subject to extensive, case-by-case, science-based food evaluation by the European Food Safety Authority (EFSA). This agency reports to the European Commission, which then drafts proposals for granting or refusing authorisation. Each proposal is submitted to the "Section on GM Food and Feed of the Standing Committee on the Food Chain and Animal Health". If accepted, it is either adopted by the EC or passed on to the Council of Agricultural Ministers. The Council has three months to reach a qualified majority for or against the proposal. If no majority is reached, the proposal is passed back to the EC, which then adopts the proposal.^[1]

The EFSA uses independent scientific research to advise the European Commission on how to regulate different foods in order to protect consumers and the environment.^[3] For GMOs, the EFSA's risk assessment includes molecular characterization, potential toxicity and potential environmental impact.^[4] Each GMO must be reassessed every 10 years.^[5] In addition, applicants who wish to cultivate or process GMOs must provide a detailed surveillance plan for after authorization. This ensures that the EFSA will know if risk to consumers or the environment heightens and that they can then act to lowed the risk or deauthorize the GMO.^[6]

As of September 2014, 49 GMO crops, consisting of eight GM cottons, 28 GM maizes, three GM oilseed rapes, seven GM soybeans, one GM sugar beet, one GM bacterial biomass, and one GM yeast biomass have been authorised.^[7]

Review of authorisation

Member States may invoke a safeguard clause to temporarily restrict or prohibit use and/or sale of a GMO crop within their territory if they have justifiable reasons to consider that an approved GMO crop may be a risk to human health or the environment. The EC is obliged to investigate and either overturn the original registrations or ask the country to withdraw its temporary restriction. By 2012, seven countries had submitted safeguard clauses. The EC investigated and rejected those from six countries ("...the scientific evidence currently available did not invalidate the original risk assessments for the products in question...") and one, the UK, withdrew.^[8]

Import rules

The EC Directorate-general for agriculture and rural development states that the regulations concerning the import and sale of GMOs for human and animal consumption grown outside the EU provide freedom of choice to farmers and consumers.^[9] All food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled. As of 2010 GMOs unapproved by the EC had been found twice and returned to their port of origin:^[1] First in 2006 when a shipment of rice from the U.S. containing an experimental GMO variety (LLRice601) not meant for commercialisation arrived at Rotterdam, the second time in 2009, when trace amounts of a GMO maize approved in the US were found in a non-GM soy flour cargo.^[1] In 2012, the EU imported about 30 million tons of GM crops for animal consumption.^[10]

Adoption of GMO crops

As of 2014 Spain has been the largest producer of GM crops in Europe with 137,000 hectares (340,000 acres) of GM maize planted in 2013 equaling 20% of Spain's maize production.^[11][12]

Smaller amounts were produced in the Czech Republic, Slovakia, Portugal, Romania and Poland.^[12] France and Germany are the major opponents of genetically modified food in Europe, although Germany has approved Amflora a potato modified with higher levels of starch for industrial purposes.^[13] In addition to France and Germany, other European countries that placed bans on the cultivation and sale of GMOs include Austria, Hungary, Greece, and Luxembourg.^[14] Poland has also tried to institute a ban, with backlash from the European Commission.^[15] Bulgaria effectively banned cultivation of genetically modified organisms on 18 March 2010.^[16]

In 2010, Austria, Bulgaria, Cyprus, Hungary, Ireland, Latvia, Lithuania, Malta, Slovenia and the Netherlands wrote a joint paper requesting that individual countries should have the right to decide whether to cultivate GM crops. By the year 2010, the only GMO food crop with approval for cultivation in Europe was MON 810, a Bt expressing maize conferring resistance to the European corn borer that gained approval in 1998.

Vandalized Amflora potato field in Zepkow, Germany.

In March 2010 a second GMO, a potato called Amflora, was approved for cultivation for industrial applications in the EU by the European Commission^[17] and was grown in Germany, Sweden and the Czech Republic that year.^[18]

Fearing that gene flow could occur between related crops, the EC issued new guidelines in 2010 regarding the co-existence of GM and non-GM crops.^[19]

Co-existence is regulated by the use of buffer zones and isolation distances between the GM and non-GM crops. The guidelines are not binding and each Member State can implement its own regulations, which has resulted in buffer zones ranging from 15 metres (Sweden) to 800 metres (Luxembourg).^[1] Member States may also designate GM-free zones, effectively allowing them to ban cultivation of GM crops in their territory without invoking a safeguard clause.^[19]

Implementation in the member states

Bulgaria

In October 2015, Bulgaria announced it has opted out of growing genetically modified crops, effectively banning the cultivation of different types of GMO corn and soybeans.^[20]

France

France adopted the EU laws on growing GMOs in 2007^[21] and was fined €10 million by the European Court of Justice for the six-year delay in implementing the laws.^[22] In February 2008, the French government used the safeguard clause to ban the cultivation of MON 810 after Senator Jean-François Le Grand, chairman of a committee to evaluate biotechnology, said there were "serious doubts" about the safety of the product.^[23] Twelve scientists and two economists on the committee accused Le Grand of misrepresenting the report and said they did not have "serious doubts", although questions remained concerning the impact of Bt-maize on health and the environment.^[24] The EFSA reviewed studies the French government had submitted to back up its claim, and concluded that there was no new evidence to undermine its prior safety findings and considered the decision "scientifically unfounded".^[25] The High Council for Biotechnology subcommittee dealing with economic, ethical and social aspects recommended an additional "GMO-free" label for anything containing less than 0.1% GMO which is due to come in late 2010.^[1][26] In 2011, the European Court of Justice and the French Conseil d'État ruled that the French farm ministry ban of MON 810 was illegal, as it failed "to give proof of the existence of a particularly high level of risk for the health and the environment".^[27]

On September 17, 2015 the French government announced it would effectively continue to ban GMO crops by enacting an "opt-out" provision, previously agreed to for the 28 EU member states in March 2015, by asking the European Commission for France to extend the GMO ban on nine additional strains of maize. The policy announcement was made simultaneously by the French farm and environment ministries. ^[28]

Germany

In April 2009, German Federal Minister Ilse Aigner announced an immediate halt to cultivation and marketing of MON 810 maize under the safeguard clause.^[29] The ban was based on "expert opinion" that suggested there was reasonable grounds to believe that MON 810 maize presents a danger to the environment.^[30] Three French scientists reviewing the scientific evidence used to justify the ban concluding that it did not use a case-by-case approach, confused potential hazards with proven risks and ignored the meta-knowledge on Bt expressing maize, instead focusing on selected individual studies.^[31]

In August 2015 Germany announced to ban genetically modified crops.^[32]

Northern Ireland

In September 2015, Northern Ireland announced a ban on genetically modified crops.^[33]

Scotland

In August 2015, the Scottish government announced that it would "shortly submit a request that Scotland is excluded from any European consents for the cultivation of GM crops, including the variety of genetically modified maize already approved and six other GM crops that are awaiting authorisation."^[34][35]

See also

• Regulation of the release of genetically modified organisms

Notes and references

See also

• European Food Safety Authority

External links

• European Food and Safety Authority
• EU Register of authorised GMOs - European Commission